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Bone & Joint Research
Vol. 7, Issue 11 | Pages 595 - 600
1 Nov 2018
Bergiers S Hothi HS Henckel J Eskelinen A Skinner J Hart A

Objectives. Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. Methods. A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The ‘pre-2007’ group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the ‘2007 onwards’ group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors. Results. There was no significant difference between the taper and bearing wear rates of the ‘pre-2007’ and ‘2007 onwards’ groups (p = 0.67 and p = 0.39, respectively). Pinnacles implanted from 2007 onwards were revised after a mean time of 50 months, which was significantly earlier than the ‘pre-2007’ hips (96 months) (p < 0.001). A reduction in the time to revision was present year on year from 2003 to 2011. Conclusion. We found no difference in the wear rate of these implants based on the year of implantation. The ‘pre-2007’ hips had a two-fold greater time to revision than those implanted after 2007; this may be due to the increased surveillance of MoM hips following UK regulatory advice and several high-profile failures. Interestingly, we observed a decreasing trend in the mean time to revision every year from 2003 onwards. Cite this article: S. Bergiers, H. S. Hothi, J. Henckel, A. Eskelinen, J. Skinner, A. Hart. Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007. Bone Joint Res 2018;7:595–600. DOI: 10.1302/2046-3758.711.BJR-2018-0143.R1


Bone & Joint Research
Vol. 5, Issue 6 | Pages 206 - 214
1 Jun 2016
Malak TT Broomfield JAJ Palmer AJR Hopewell S Carr A Brown C Prieto-Alhambra D Glyn-Jones S

Objectives. High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). Methods. We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. Results. Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. Conclusions. This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance. Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint Res 2016;5:206–214. DOI: 10.1302/2046-3758.56.2000568


Bone & Joint Research
Vol. 8, Issue 3 | Pages 146 - 155
1 Mar 2019
Langton DJ Natu S Harrington CF Bowsher JG Nargol AVF

Objectives

We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr.

Methods

For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood.


Bone & Joint Research
Vol. 5, Issue 9 | Pages 379 - 386
1 Sep 2016
Pahuta M Smolders JM van Susante JL Peck J Kim PR Beaule PE

Objectives

Alarm over the reported high failure rates for metal-on-metal (MoM) hip implants as well as their potential for locally aggressive Adverse Reactions to Metal Debris (ARMDs) has prompted government agencies, internationally, to recommend the monitoring of patients with MoM hip implants. Some have advised that a blood ion level >7 µg/L indicates potential for ARMDs. We report a systematic review and meta-analysis of the performance of metal ion testing for ARMDs.

Methods

We searched MEDLINE and EMBASE to identify articles from which it was possible to reconstruct a 2 × 2 table. Two readers independently reviewed all articles and extracted data using explicit criteria. We computed a summary receiver operating curve using a Bayesian random-effects hierarchical model.


Bone & Joint Research
Vol. 6, Issue 7 | Pages 405 - 413
1 Jul 2017
Matharu GS Judge A Murray DW Pandit HG

Objectives

Few studies have assessed outcomes following non-metal-on-metal hip arthroplasty (non-MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD). We assessed outcomes following non-MoMHA revision surgery performed for ARMD, and identified predictors of re-revision.

Methods

We performed a retrospective observational study using data from the National Joint Registry for England and Wales. All non-MoMHAs undergoing revision surgery for ARMD between 2008 and 2014 were included (185 hips in 185 patients). Outcome measures following ARMD revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using Cox regression.


Bone & Joint Research
Vol. 1, Issue 4 | Pages 42 - 49
1 Apr 2012
Kwon Y Mellon SJ Monk P Murray DW Gill HS

Objectives

Pseudotumours (abnormal peri-prosthetic soft-tissue reactions) following metal-on-metal hip resurfacing arthroplasty (MoMHRA) have been associated with elevated metal ion levels, suggesting that excessive wear may occur due to edge-loading of these MoM implants. This study aimed to quantify in vivo edge-loading in MoMHRA patients with and without pseudotumours during functional activities.

Methods

The duration and magnitude of edge-loading in vivo was quantified during functional activities by combining the dynamic hip joint segment contact force calculated from the three-dimensional (3D) motion analysis system with the 3D reconstruction of orientation of the acetabular component and each patient’s specific hip joint centre, based on CT scans.